Archive for November, 2009

Correction for Gardasil Blog 117 from AHRP

Monday, November 30th, 2009

ALLIANCE FOR HUMAN RESEARCH PROTECTION

 Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org 

Please note that some of the conclusions (value judgments) that were made in the Infomail re: Gardasil, http://www.ahrp.org/cms/content/view/642/9/ should NOT be attributed to Dr. Diane Harper, whose presentation at the International Public Conference on Vaccination, was more nuanced than the Philadelphia Bulletin reported. Dr. Harper presented the following facts:

1. “70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer;”

 2. “There have been no efficacy trials in girls under 15 years.” “There also is not enough evidence gathered on side effects to know that safety is not an issue.”

3. “To date, 15,037 girls have officially reported adverse side effects from Gardasil to the U.S. Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guilliane Barre, lupus, seizures, paralysis, blood clots, brain inflammation and many others. The CDC acknowledges that there have been 44 reported deaths.”

Dr. Harper did not draw conclusions about whether (or not) to vaccinate–except to say, “It is silly to mandate vaccination of 11 to 12 year old girls” given the lack of efficacy and safety data…

The statement: “the incidence of cervical cancer in the U.S. is already so low that “even if we get the vaccine and continue PAP screening, we will not lower the rate of cervical cancer in the US.” is a quote from a published article by scientists at the National Cancer Institute:

“I came away from the talk with the perception that the risk of adverse side effects is so much greater than the risk of cervical cancer, I couldn’t help but question why we need the vaccine at all,” said Joan Robinson, Assistant Editor at the Population Research Institute.

Contact: Vera Hassner Sharav veracare

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Can You Prevent Cancer with Diet?

Tuesday, November 17th, 2009

For the past few years the “battle against cancer” includes taking lots of fruits and vegetables-five servings a day-and ingesting vitamins, especially vitamin E and beta carotene, and the mineral selenium. But other measures that are often assumed — and marketed — as ways to prevent cancer are either wrong-headed or nonsensical according to researchers.

The evidence about fruits and vegetables is vague, “far from definitive,” and therefore unproven. Fiber, found in fruits, vegetables and grains, has been touted to prevent colon cancer, even though two large studies found no effect. As for low-fat diets, long advertised to prevent breast cancer, a large federal study randomizing women to a low-fat or normal diet and looking for an effect in breast cancer found nothing.

Then there’s exercise and weight loss, always a good bet to achieve longevity and glowing health. Studies have associated strenuous exercise with less cancer. But that is the same sort of evidence that misled scientists about aspects of diet. “I think it’s wishful thinking,” said Dr. Susan Love, a breast surgeon. “We would like things to be more in our control. I think that’s part of it. And in the absence of anything else, what do we tell women about how to prevent breast cancer? We tell them to exercise and eat a good diet.”

Another study proposed would have been the largest cancer prevention clinical trial ever attempted, involving 35,000 men 50 and older. This time the idea was that vitamin E and selenium might prevent prostate cancer.

The selenium and vitamin E study ended early. Once again, there was no protection from cancer, and there were hints the supplements might be causing cancer. The great hope, after more millions spent on scientific imaginings, again turned into profound disappointment.

Other measures that are often assumed — and marketed — as ways to prevent cancer may not make much difference, researchers say. The key word is “marketed,” or is it “junk science”?




Medical Devices: Awaiting the Data?

Tuesday, November 10th, 2009

Medical device manufacturers objected strenuously to the recently passed Congressional Health Act which requires them to report sales volumes for a device registry. Neither Senate health bill coming up contains this provision. Unless the House provisions are preserved, researchers will continue to be denied funding to gather critical data. This is the only way to determine the types of patients who would most benefit from a defibrillators, joint replacements, and other devices. Without follow-up on outcomes, medical opinion will remain divided. We still won’t know how products compare with each other how many people really need a specific device, and which patients will be harmed.

Device manufacturers object, of course, to the 2.5% excise tax on medical devices in the House bill, which could generate $20 billion in federal revenues over 10 years. But note that the average profit reported by device makers is over 20% of sales.





Medical Devices: Disturbing News

Friday, November 6th, 2009

Implanted heart defibrillators cost around $25,000 each, but which patients will require or be benefited by having one remains uncertain. In 2004 Government and industry stuck a deal. Medicare agreed to expand the device’s use, nearly doubling the number of patients who qualified for one. The companies, in return, agreed to pay for a study to see which patients really benefited. But the companies reneged, backing out after putting in a measly $4 million, and the Government of the last Administration did not pick up the remaining tab. As a result, researchers still cannot gather data to determine the types of patients who would most benefit from a defibrillator, and doctors keep implanting them in patients who may not benefit at all. Many of these patients may even be harmed, especially if the device has to be removed, a dangerous procedure-something that often occurs, particularly when the batteries ultimately fail. No one even knows whether one producer’s model performs better than a competitor’s.

The problem is not limited to defibrillators or even cardiac stents. Tens of thousands of artificial hips, knees, and now shoulders are implanted every year. Doctors placing these devices have little or no reliable comparative data on which brands last longest or work best in a given patient. According to the McKinsey Global Institute, a consulting group, expenditures on implanted devices stand at about $76 billion annually in this country and are rising at a rate faster than the cost of drugs. (See this excellent article in the New York Times.)

Unlike other hospital products, implants are so-called physician preference items, meaning that doctors — not the hospitals — often choose which manufacturer’s implant to use. Profit margins on medical devices are also among the highest for any medical products, over 20% in the case of a defibrillator or an artificial hip, according to analysts.





Medical Loss Ratio and other Confusions

Thursday, November 5th, 2009

A revealing phrase: “Medical Loss Ratio,” is the health insurance industry’s jargon for percentage of premiums spent on medical claims. The critical word “loss” amounts to a negative self-perception of the industry’s mission. The rest of the money they acquire from you and me is spent on “administrative” costs such as negotiating with providers such items as approval for tests, operations, referrals, the cost of billing, and employee salaries, bonuses, marketing, and company and shareholder profits. This overhead has long been reported by many authorities-and companies- to be around 15%, supposedly leaving 85% of your health care costs, their medical loss ratio, to pay your medical, hospital, drug, and other health-related bills.

But a new Senate analysis suggests that for-profit insurance companies are spending much less than that on patient care, especially for policies sold to individuals and small businesses. According to the New York Times, as little as 66 cents of each dollar paid in premiums goes toward doctor and hospital bills, while the rest covers administrative expenses, marketing and company profits.

The data come from an analysis of regulatory filings by the Senate Commerce Committee from the largest for-profit companies, including WellPoint, the UnitedHealth Group, Aetna and Cigna. They spent about 74 cents out of every dollar on medical care in the individual market, according to the information released by Senator John D. Rockefeller IV, chairman of the commerce committee.

But according to this source, Medicare’s claim that their overhead costs are only 2%-5% is clearly disingenuous since they do not count the (unknown) cost of all the Government unfunded mandates, rules, and regulations on medical providers, let alone insurers. This paper empire imposes huge costs, which of course are passed on to patients and taxpayers. But then so do the insurance companies impose regulatory costs-theirs and the Government’s. These too are passed on to patients (and taxpayers.) The total cost of all this federal regulation is unknown and probably impossible to calculate.

Still, as Senator Rockefeller said in a recent statement, the insurers “need to tell us how they are spending their customers’ money. Are they spending it to make people well when they are sick and keep them healthy?” he asked. “Or is the money they charge going to profits, to executive salaries, and to figuring out how to deny care to people when they really need it?”